Director, CMC Regulatory Affairs

Director, CMC Regulatory Affairs

Introduction:

Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit www.xencor.com. We have an excellent opportunity for a Director, CMC Regulatory Affairs, to join our team.

This position can be hybrid out of our San Diego, CA office or fully remote

Summary:

The Director of Regulatory Affairs CMC will be responsible, in conjunction with RA CMC management, for the development and execution of global regulatory CMC strategies. Successful execution of this role includes ensuring that regulatory strategies are effectively implemented and maintained in line with changing regulatory and business needs. The Director RA CMC will identify and gather data needed to support regulatory submissions, responses to inquiries, and dossier maintenance to meet relevant global regulatory requirements. They will manage regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure. The successful candidate will exhibit strong technical expertise and a willingness to work both strategically and hands-on.

Job Duties:

• Oversees and executes global Chemistry, Manufacturing and Controls (CMC) regulatory strategies and submissions, for product registrations (INDs, NDAs, IMPDs, CTAs, MAAs, DMFs, Amendments, Variations, etc.)
• Collaborates with CMC team on RA strategy for new manufacturing processes and manufacturing changes
• Represents RA CMC on cross functional teams for externally manufactured clinical drug substance and drug products
• Develops integrated RA CMC strategies with cross functional stakeholders
• Leads Regulatory submission process by collaborating and coordinating with relevant team members and participating in Core and Sub Team activities
• Manages regulatory aspects of projects in collaboration with multidisciplinary teams according to project plans, timelines, and budgets
• Drafts, edits, critically reviews CMC sections of regulatory submissions.
• Provides submission-ready documents to publishing function:
• Contributes to quality related functions such as GMP requirements, draft and review of SOP's, review of quality and supplier agreements
• Utilizes regulatory strategies and plans that align with overall project plans and business strategy
• Under direction of, and in conjunction with, RA CMC senior management:
  • Leads effort to prepare US-centric and global regulatory submissions
  • Participates in preparation of regulatory meeting packages and as required. Attends Regulatory Authority meetings
  • Supports and executes strategic plans and initiatives as defined by RA CMC senior management
• Assists with management and oversight of regulatory activities relating to global clinical trials on assigned projects
• Assists with leadership of the regulatory team and provides guidance pertaining to regulatory matters to the organization
• Provides regulatory review of clinical product labeling
• Represents Xencor's interests with national government agencies, industry associations and/or other organizations with legislation, regulations and/or guidelines that impact the business in global markets
• Adheres to all department and company-wide policies regarding conduct, performance and procedures
• Provides oversight and direction to direct and indirect reports, as applicable in accordance with the organization’s policies and procedures.  The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities
• Performs other duties as assigned.

Education/Experience/Skills:

Position requires a Bachelor’s degree in a chemistry/engineering discipline or closely related field. Advanced degree is preferred, and at least 12 years of experience in the pharmaceutical/biotech industry, including direct experience in CMC. Requires experience authoring CMC sections of global regulatory filings, including US, Europe, Canada and APAC and significant experience with CTD format and content of regulatory filings. Significant and skilled experience in technical writing, editing and use of MS Word and Adobe Acrobat also required   Knowledge of process development/manufacture and analytical methodology development/validation and experience in formulation/process development preferred.

Position also requires:

• Strong knowledge of current US and EU regulations and cGMPs

• Written communication skills which adhere to correct grammatical rules, including proper sentence structure, verb tense consistency, and correct punctuation.
• Strong problem solving and leadership skills
• Strong understanding of CTD structure and basic aspects of regulatory publishing processes
• Ability to work effectively with regulatory publishing group and processes to produce high quality regulatory submission documentation
• Ability to use written and verbal communication skills to communicate complex scientific, medical and program issues
• Ability to partner effectively with cross-functional teams from research, pre-clinical development, manufacturing, quality and clinical development
• Flexibility and adaptability suited for the changing requirements and fast pace of a small biotechnology company
• Knowledge of computer software, including relevant applications such as MS Word, Excel, and PowerPoint
• Familiarity with relevant laws, legal codes, government regulations and agency rules
• General understanding of ICH, GLP, cGMP requirements and GXP regulations
• Attention to detail, organizational skills, ability to multitask and follow tasks through to completion
• Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model
• Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices.  Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment.

Physical, Mental and Environment Demands:

The physical, mental and working environment demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply.

Specific mental demands for the position are listed above under requirements.  In addition, mental demands for this position include:

• Ability to multitask without loss of efficiency or accuracy, including the ability to perform multiple duties from multiple sources
• Ability to work and sustain attention with distractions and/or interruptions
• Ability to interact appropriately with a variety of individuals including vendors, customers and clients
• Ability to maintain regular attendance and be punctual
• Ability to understand, remember and follow verbal and written instructions.

Occasional travel may be required, including travel between Xencor’s Pasadena and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Expected Base Salary Range: $195,500 - $236,000

The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits.  In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/.

Xencor requires all employees to be fully vaccinated against COVID-19 as a condition of employment.  Being fully vaccinated means that at least two weeks have passed since an individual’s final dose of an authorized COVID-19 vaccine regimen.  New employees will be required to provide proof of their COVID-19 vaccination status as of their start date unless an exemption or accommodation is approved.

 Americans with Disabilities Act (ADA) Statement

The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact HR@xencor.com.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Equal Employment Opportunity (EEO) Statement

The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law.

Xencor does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor, implied or otherwise.